Sjögren's SyndromeNCT03983408
Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
A study testing Korean Red Ginseng in people with Sjögren's Syndrome and Rheumatic Diseases, run by Hanyang University at 1 site in South Korea.
Trial summary
The objective of a randomized, double-blind, placebo-controlled trial and open-label extension study is to figure out the impact of Korean Red Ginseng (KRG) on fatigue in patients with rheumatic diseases. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Sjögren's Syndrome, Rheumatic Diseases, Korean Red Ginseng
- What is being tested?
- Korean Red Ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet for Classification Criteria for Sjögren's syndrome
- Patients who have experienced fatigue for over 3 months
- Patients aged ≥ 19 and <75
- Patients who provide a written consent of participating in this study.
Who cannot join
- Patients who have experienced hypersensitivity or adverse events to Korean Red ginseng
- Patients who used dietary supplements containing KRG during recent 2 months
- Patients who are pregnant or breast-feeding
- Patients who use oral glucocorticoids or opioids continuously
- Patients who had other comorbidities which could lead to fatigue as symptoms including chronic kidney disease, chronic liver disease, endocrine disoders, malignancy, or depression.
- Patients having fibromyalgia or chronic fatigue syndrome
- Patients who presented abnormal laboratory findings at the time of enrollment White blood cell (WBC) ≤ 3.5 x 10^9/L or, Hemoglobin (Hb) ≤ 8.5 g/dL or, Platelet (PLT) ≤ 100 x 10^9/L or, Serum creatinine (Cr) ≥ 2.0 mg/dL or, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≥ 2.5 times of upper limits of normal
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University
Seoul, 04763
Yoon-Kyoung Sung, MD, PhD, MPH, 82-2-2290-9250, sungyk@hanyang.ac.kr
About this study
The objective of a randomized, double-blind, placebo-controlled trial and open-label extension study is to figure out the impact of Korean Red Ginseng (KRG) on fatigue in patients with rheumatic diseases.
Read the detailed description
Primary objective
: Improvement of fatigue after using KRG in patients with rheumatic diseases according to
Secondary objectives
- Improvement of dryness after using KRG in patients with rheumatic diseases according to EULAR Sjögren's syndrome disease activity index (ESSDAI)
- Improvement of quality of life after using KRG in patients with rheumatic diseases according to EuroQol 5 dimensions questionnaire (EQ-5D)
The study population will be adult patients with rheumatic diseases, especially primary or secondary Sjögren's syndrome who have experienced dryness for more than 3 months. Participants are ramdomly assigned to KRG and placebo group and they are using KRG or placebo for the first 12 weeks. After 12 weeks, the concealment of allocation is lifted and all patients are provided with KRG for next 12 weeks with open-label extension study
- Conditions
- Sjögren's Syndrome, Rheumatic Diseases, Korean Red Ginseng
- Being tested
- Korean Red Ginseng, Placebo
- Keywords
- Sjögren's Syndrome, Korean Red Ginseng
- Medical subject headings
- Sjogren's Syndrome, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red GinsengDietary supplement
Also called KRG
Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.
PlaceboDietary supplement
Placebo tablets, made of corn starch and cellulose, are manufactured to mimic KRG tablets. Participants are parovided with 2 placebo tablets twice a day for first 12 weeks, following Korean Red Ginseng extract tablets twice a day for another 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| KRG group | Active comparator | * Enrollment: 60 patients
* Drug: Korean Red Ginseng (KRG) 2,000 mg/day for total 24 weeks (2 Korean Red Ginseng extract tablet twice a day, ginsenoside Rg1+Rb1+Rg3 7.0 mg/g per each tablet) Receives: Dietary Supplement: Korean Red Ginseng |
| Placebo group | Placebo comparator | * Enrollment: 60 patients
* Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)
Improvement of FACIT-F after using KRG
Measured: 12 weeks
Secondary outcomes (3)
Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued])
Improvement of FACIT-VAS after using KRG
Measured: 12 weeks
ESSDAI (The EULAR Sjögren's syndrome [SS] disease activity index, total score ranged 0 to 123, higher scroes indicate severe systemic disease activity)
Improvement of ESSDAI after using KRG
Measured: 12 weeks
EuroQol 5 dimensions questionnaire (EQ-5D, a person's health status is defined by a 5-digit number, ranging from 11111 [having no problems in all dimensions] to 33333 [having extreme problems in all dimensions])
Improvement of EQ-5D after using KRG
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start17 Jun 2019
- Primary completion31 Aug 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Ginseng
- Responsible party
- Principal investigator, Yoon-Kyoung Sung, Hanyang University
- Investigators
- Yoon-Kyoung Sung, MD, PhD, MPH, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983408
- Sponsor's protocol ID
- HUHRD-SPE-19-01
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not shared with other researchers
Publications
Cho SK, Kim D, Yoo D, Jang EJ, Jun JB, Sung YK. Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study. J Ginseng Res. 2018 Apr;42(2):144-148. doi: 10.1016/j.jgr.2017.01.006. Epub 2017 Jan 20.
PubMed 29719460
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
- ClinicalTrials.gov ID
- NCT03983408
- Acronym / sponsor ID
- HUHRD-SPE-19-01
- Conditions
- Sjögren's Syndrome, Rheumatic Diseases, Korean Red Ginseng
- Keywords
- Sjögren's Syndrome, Korean Red Ginseng
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- The Korean Society of Ginseng
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of a randomized, double-blind, placebo-controlled trial and open-label extension study is to figure out the impact of Korean Red Ginseng (KRG) on fatigue in patients with rheumatic diseases.
Detailed description
Primary objective
: Improvement of fatigue after using KRG in patients with rheumatic diseases according to
Secondary objectives
- Improvement of dryness after using KRG in patients with rheumatic diseases according to EULAR Sjögren's syndrome disease activity index (ESSDAI)
- Improvement of quality of life after using KRG in patients with rheumatic diseases according to EuroQol 5 dimensions questionnaire (EQ-5D)
The study population will be adult patients with rheumatic diseases, especially primary or secondary Sjögren's syndrome who have experienced dryness for more than 3 months. Participants are ramdomly assigned to KRG and placebo group and they are using KRG or placebo for the first 12 weeks. After 12 weeks, the concealment of allocation is lifted and all patients are provided with KRG for next 12 weeks with open-label extension study
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KRG group | Active comparator | Dietary Supplement: Korean Red Ginseng* Enrollment: 60 patients * Drug: Korean Red Ginseng (KRG) 2,000 mg/day for total 24 weeks (2 Korean Red Ginseng extract tablet twice a day, ginsenoside Rg1+Rb1+Rg3 7.0 mg/g per each tablet) |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo* Enrollment: 60 patients * Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who meet for Classification Criteria for Sjögren's syndrome
- Patients who have experienced fatigue for over 3 months
- Patients aged ≥ 19 and <75
- Patients who provide a written consent of participating in this study.
Key exclusion criteria (7 listed)
- Patients who have experienced hypersensitivity or adverse events to Korean Red ginseng
- Patients who used dietary supplements containing KRG during recent 2 months
- Patients who are pregnant or breast-feeding
- Patients who use oral glucocorticoids or opioids continuously
- Patients who had other comorbidities which could lead to fatigue as symptoms including chronic kidney disease, chronic liver disease, endocrine disoders, malignancy, or depression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean Red GinsengAlso: KRGParticipants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks. | Dietary supplement | KRG group |
| PlaceboPlacebo tablets, made of corn starch and cellulose, are manufactured to mimic KRG tablets. Participants are parovided with 2 placebo tablets twice a day for first 12 weeks, following Korean Red Ginseng extract tablets twice a day for another 12 weeks. | Dietary supplement | Placebo group |
Primary outcome
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)
Time frame: 12 weeks
Improvement of FACIT-F after using KRG
3 secondary outcomes
Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued])
Time frame: 12 weeks
ESSDAI (The EULAR Sjögren's syndrome [SS] disease activity index, total score ranged 0 to 123, higher scroes indicate severe systemic disease activity)
Time frame: 12 weeks
EuroQol 5 dimensions questionnaire (EQ-5D, a person's health status is defined by a 5-digit number, ranging from 11111 [having no problems in all dimensions] to 33333 [having extreme problems in all dimensions])
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 29719460Cho SK, Kim D, Yoo D, Jang EJ, Jun JB, Sung YK. Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study. J Ginseng Res. 2018 Apr;42(2):144-148. doi: 10.1016/j.jgr.2017.01.006. Epub 2017 Jan 20.
- Individual participant dataSharing planned: No. IPD is not shared with other researchers
Related trials for Sjögren's Syndrome
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
RecruitingPhase 2
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Sjögren's Disease
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-Kyoung Sung, MD, PhD, MPH principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Korean Red Ginseng in people with Sjögren's Syndrome and Rheumatic Diseases, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoon-Kyoung Sung, MD, PhD, MPH (82-2-2290-9250, sungyk@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03983408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.